Senior CSV Specialist

Title: Senior CSV Specialist Location: Hybrid (US site or remote with periodic travel) Experience: 10+ years Duration: 6–12 months contract (extendable)

Position Overview

We are seeking an experienced Senior CSV Specialist to drive Computer System Validation (CSV/CSA) strategy and execution across a portfolio of GxP-regulated systems including MES, LIMS, QMS, ERP, and Data Historian.

This role will serve as the validation workstream lead , collaborating with IT, QA, and Manufacturing teams to ensure all systems comply with GAMP 5 , 21 CFR Part 11 , Annex 11 , and data integrity standards. The ideal candidate will have a strong background in risk-based validation (CSA) and hands-on experience managing validation programs from initiation through inspection readiness in global pharmaceutical or biotech environments.

Key Responsibilities

Lead all CSV/CSA activities across assigned IT systems, ensuring compliance with global validation strategy and site quality standards.

Develop and maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Test Protocols (IQ/OQ/PQ).

Define validation strategies for both new and legacy systems, applying risk-based and CSA principles.

Conduct cross-functional reviews with QA, IT, and business stakeholders to ensure consistency and audit readiness.

Mentor validation engineers and documentation specialists to ensure high-quality, compliant deliverables.

Oversee vendor assessments, supplier qualification, and validation of GxP cloud/SaaS platforms (e.g., AWS, Azure).

Interface with auditors and regulatory inspectors, presenting validation strategies and supporting documentation.

Drive continuous improvement of validation templates, SOPs, and processes.

Support change control, deviation management, CAPA, and periodic review processes for validated systems.

Required Experience

10+ years of Computer System Validation experience within pharmaceutical or biotech environments.

Proven track record leading CSV/CSA activities for GxP systems such as:

MES (Syncade, PAS-X)

LIMS (LabVantage, LabWare)

QMS (Veeva, TrackWise)

ERP (SAP S/4)

Data Historian (OSI PI)

Deep understanding of GAMP 5 , 21 CFR Part 11 , Annex 11 , ALCOA+ , and data integrity principles.

Experience leading validation strategy for multi-site or global implementations.

Familiarity with Agile/DevOps validation and digital transformation initiatives (e.g., cloud migration, SaaS qualification).

Strong documentation and review skills across the validation lifecycle.

Excellent communication and stakeholder management abilities across IT, QA, and Manufacturing.